Field of Invention
The present disclosure relates generally to medical methods, systems and apparatuses, and more particularly, to methods, systems and apparatus for detecting and indicating one or more surgical aspects of a medical procedure.
Description of Related Art
Ophthalmic surgical apparatuses typically include operating controls for regulating settings or functions of the apparatus. Numerous types of apparatuses include, as part of the apparatus, a hand-held medical implement or tool, such as a handpiece with a tip. Operation of the tool requires control of various operating settings or functions based on the type of tool used and the type of operation being performed. Such apparatuses typically include a control module, power supply, an irrigation source, one or more aspiration pumps, as well as associated electronic hardware for operating a multifunction handheld surgical tool in order to emulsify eye tissue, irrigate the eye with a saline solution, and aspirate the emulsified lens from the eye.
A number of medically recognized techniques are utilized for crystalline lens removal based on a variety of technologies, for example, phacoemulsification or vitrectomy. Phacoemulsification and vitrectomy procedures may require fluid control, namely control over aspiration and irrigation to the ocular region, and employ a handpiece that is typically electrically driven and must be controlled. The handpiece or similar apparatus is especially constructed for breaking apart and removing the natural, crystalline lens of a patient's eye, in preparation for insertion of an artificial lens. A phacoemulsification apparatus may involve a console that contains or holds the control module, power supply, and irrigation source, with the console being movable so that these components can be arranged in a beneficial manner during a procedure, typically just outside of the surgical procedure area. The handpiece is arranged to extend into the surgical procedure area, specifically the ocular region.
It should be appreciated that controlling or changing the functions or operations of the handpiece from the remote console or control module is generally unsatisfactory for the surgeon or operator of the handpiece during a surgical operation. During operation, the surgeon's focus should optimally be on the surgical area, not the remote console. Accordingly, in view of the handheld instrumentation necessary for a phacoemulsification procedure, foot controls are frequently provided in order to control and facilitate use of the handpiece, such as a fluid handpiece during surgery, and control of the handpiece may be provided to the surgeon via a foot pedal. Foot pedals vary in design, but more modern foot pedals include a treadle that can be moved in a fore-and-aft direction (a pitch motion) and in a left-and-right direction (a yaw motion). Hard switches may also be provided, where the switches typically provide a toggle functionality and/or an on-off functionality. Control may be provided for various device components and operations for the phacoemulsification, diathermy or vitrectomy machine through the foot pedal, including control of fluid flow, entry into various modes, electrical parameters, speed parameters (e.g. cut speed), and so forth. Despite the output from such foot pedals in regulating or controlling the apparatus, the pedal, and the entire system, must be user friendly in order to provide a surgeon comfort and reliability in its use so as not to initiate disruption of the surgeon's concentration when performing surgery.
Phacoemulsification includes making a corneal and/or scleral incision and the insertion of a phacoemulsification handpiece that includes a needle or tip that is ultrasonically driven to emulsify, or liquefy, the lens. A phacoemulsification system typically includes a handpiece coupled to an irrigation source and an aspiration pump. In various embodiments, the handpiece includes a distal tip that emits ultrasonic energy to emulsify a crystalline lens within the patient's eye. The handpiece includes an irrigation port proximal to the distal tip and coupled to the irrigation source via an irrigation input line. The handpiece further includes an aspiration port at the distal tip that is coupled to the aspiration pump via an aspiration output line. Concomitantly with the emulsification, fluid from the irrigation source (which may be a bottle or bag of saline solution that is elevated above the field of surgery) is irrigated into the eye via the irrigation line and the irrigation port. This fluid is directed to the crystalline lens in the patient's eye in order to maintain the anterior chamber and capsular bag and replenish the fluid aspirated away with the emulsified crystalline lens material. The irrigation fluid in the patient's eye and the crystalline lens material are aspirated or removed from the eye by the aspiration pump and line via the aspiration port. Additionally, some procedures may include irrigating the eye and aspirating the irrigation fluid without concomitant destruction, alteration or removal of the lens.
Phacoemulsification and vitrectomy procedures typically require precise fluid control, namely control over aspiration and irrigation to the ocular region, and employ a handpiece that is typically controlled electrically in order to, for example, precisely control the flow of fluid through the handpiece and tip. Such control is necessary, for example, to maintain a stable volume of liquid in the anterior chamber of the eye, which may be accomplished by irrigating fluid into the eye at the same rate as fluid and/or lens material is aspirated from the eye. During such operations, however, it is possible for the flow of fluid out of or into the handpiece to be occluded or blocked. Such an occlusion may occur, for example, from particles (e.g. particles from the crystalline lens) blocking a port, lumen or tube associated with the irrigation input line or the aspiration output line. Such blockage can disrupt the flow of fluid into or out of the eye, for example, by creating an imbalance of fluid flow that can result in an increased negative pressure in the eye. Conversely, such a blockage could result in a volumetric fluid flow drop off near the aspiration port. For such surgical procedures, it is necessary for the surgeon or other medical personnel to understand and account for specific aspects of the surgical procedure, such as whether a stable volume of fluid is in the eye or whether an occlusion has occurred, in order to effectively perform the operation.
In prior systems, the occurrence of an occlusion has been communicated to a surgeon or user via either an audio tone or a visual indicator on a display associated with a control module of the surgical apparatus. A computer system associated with the control module may be electronically connected to a sensor that monitors the flow of fluid into and out of the handpiece, or a sensor that otherwise detects changes in the rate of fluid flow into the eye or the pressure of the fluid in the eye, in order to determine if an occlusion has occurred. Such a system may be able to detect small changes in the fluid flow rate that would otherwise go unappreciated (or be mistaken) by a surgeon or other user of the handpiece. A pre-determined amount of flow rate change may be programmed into the system, such that if the flow rate change reaches or surpasses the pre-determined amount, the system will know that an occlusion is occurring or has occurred. Other forms of detecting the occurrence of an occlusion are known in the art.
Once an occlusion has been detected, the system will typically sound an audio alarm or provide a visual indicator on the display screen to inform the surgeon of the occlusion. However, such systems have various disadvantages. For instance, use of an audio tone can be distracting or startling to a surgeon or user of the handpiece, who are required to perform detailed and specific movements of the handpiece during a surgical operation. An audio tone may also be startling or intimating for the patient undergoing the surgical procedure. While a traditional audible tone may be enabled or disabled and the volume adjusted, the nature of how occlusions occur, and clear, sometimes results in the rapid cycling of the audible tone (as multiple occlusions occur and clear in quick succession, for example). Such an audible tone may be so distracting that a surgeon prefers to turn the tone off completely.
Alternatively, use of a visual indicator on a display may also be problematic because such visual indicator is displayed on the console of the surgical apparatus. A surgeon is not typically looking at, or even using, a console display while performing surgery, instead keeping the focus of their attention on the patient and the procedure being performed with the handpiece. In illustrative examples, a surgeon may actually be viewing the patient's eye through a surgical microscope and has no view of the console display. One alternative to this is to increase the visual effect of the indicator (larger, brighter, etc.), however if a visual indicator is substantial enough, it can also have the effect of distracting or startling the surgeon and/or patient, as discussed above.
Based on the foregoing, it would be advantageous to provide a means of notification of automatic detection of an occlusion to a surgeon without interruption or distraction to the surgeon or patient during surgery. Such a design would afford a surgeon the ability to perform desired phacoemulsification, diathermy, or vitrectomy functions with less need to worry about an abrupt audio tone, or a potentially unnoticed or distracting visual indicator, when an occlusion is occurring or has occurred. Moreover, such a design would reduce the introduction of human error that can occur during the surgical procedure that occurs because the surgeon is startled by, or does not understand the reason for, the audio or visual signal.